After Mastectomy in Breast Cancer Patients, Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
After Mastectomy in Breast Cancer Patients, Prospective and Retrospective Study to Evaluate the Clinical Effectiveness and Safety of Supercritical Carbon Dioxide Processed Acellular Dermal Matrix(SC DERM® Recon) in Breast Reconstruction
This study is a multicenter, open-label study with both prospective and retrospective components, enrolling up to 120 subjects undergoing breast reconstruction using acellular dermal matrix (ADM).
The primary objective of this study is to evaluate differences in complication rates between the test group undergoing breast reconstruction with SC Derm and the control group undergoing breast reconstruction with other ADM products.
In South Korea, breast reconstruction using implants or autologous abdominal tissue is commonly performed to address the aesthetic and psychological needs of patients who have undergone total mastectomy for breast cancer. In such procedures, acellular dermal matrix (ADM) is used to compensate for soft tissue and skin deficits resulting from tumor resection.
This clinical study is designed to evaluate differences in clinical efficacy, aesthetic outcomes, and safety between ADM processed using supercritical carbon dioxide technology and conventional ADM products in breast reconstruction surgery.
The test group will prospectively enroll 60 patients undergoing breast reconstruction using SC Derm (an investigational ADM processed with supercritical carbon dioxide technology). The control group will retrospectively include 60 patients who underwent breast reconstruction using other ADM products, based on medical records from 2022.
Inclusion Criteria:
Exclusion Criteria: